The feasibility of oral anticoagulant drug adjustments based on brain imaging evaluation in patients with atrial fibrillatio

Phase 2

• Conditions: Atrial fibrillation (AF); Anticoagulant therapy; Silent brain infarct (SBI); Cerebral microbleed (CMB); Cerebral small vessel disease (CSVD); Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Stroke - Haemorrhagic; Stroke - Ischaemic

• Registration Number: ACTRN12623000949684
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-04
• Last Update Posted: 12 September 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Adults (age >=18 years).
2.Have non-valvular atrial fibrillation (AF) or atrial flutter (AFL) as documented by electrocardiography (ECG) (12-lead ECG, rhythm strip, or Holeter) in the past 6 months before enrolment, regardless of AF clinical patterns.
3.Take OAC at study entry or willing to receive OAC for thromboprophylaxis without any contradiction, and standard-dose OAC is appliable.
4.Willing to undergo brain MRI.
5.Willing to participate after being told the trial information (purpose and procedures) and provide written informed consent by the participant or an appropriate legal surrogate.

Exclusion Criteria

1.History of heart valve disease (i.e., prosthetic valve or hemodynamically relevant valve disease).
2.AF or AFL due to reverse causes of cardiac surgery, pulmonary embolism, and untreated hyperthyroidism.
3.Known presence of atrial myxoma, left ventricular thrombus, or active endocarditis.
4.Severe, disabling stroke (modified Rankin scale [mRS] score of 4 to 5) within the past 3 months, or any stroke within the past 14 days, or TIA within 3 days before enrolment.
5.An obvious impairment of renal function (serum creatine >=1.5 mg/dL [133 µmol/L] or creatinine clearance [CrCL, Cockcroft-Gault Equation] <= 50 mL/min) or hepatic function (persistent alanine transaminase [ALT], aspartate transaminase [AST], or alkaline phosphatase [ALP] >3x upper limit of the normal range [ULN], acute clinical hepatitis, chronic active hepatitis, or cirrhosis).
6.Any other conditions associated with increased bleeding risk including:
a.Major surgery within the past 2 months or planned surgery or intervention within the next 3 months.
b.Anemia (hemoglobin level <100 g/L) or thrombocytopenia (platelet count <100/µL).
c.Gastrointestinal (GI) hemorrhage within the past 6 months or symptomatic gastroduodenal ulcer disease documented by endoscopy in the previous 30 days.
d.Sustained uncontrolled hypertension (systolic blood pressure [SBP] >180 mmHg and/or diastolic blood pressure [DBP] >100 mmHg).
e.Needs anticoagulant therapy for disorders other than AF.
f.Known intracranial neoplasm, arteriovenous malformation (AVM), or aneurysm before randomisation.
7.Not eligible for MRI examination, such as decompensated heart failure that hinders flat lying during MRI scanning, claustrophobia, and metallic foreign body or iatrogenic implantable device contradicted to MRI.
8.Have malignancy or other serious concomitant diseases with a life expectancy of <2 years.
9.Women who are pregnant or of childbearing potential who refuse to use medically acceptable contraception throughout the trial.
10.Participating in another trial of anticoagulant therapy that conflicts with the ECHOES-AF Pilot.
11.Any other condition, in the opinion of investigators, that renders the patient unsuitable for the trial and would compromise adherence and safe participation (e.g. drug addiction, alcohol abuse, etc.).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of enrolled participants (eligible and consented) from those screened (an audit of study enrolment/withdrawal logs)[One year after randomisation];The number of site activation over time (an audit of study enrolment/withdrawal logs)[One year after randomisation];The number of enrolled participants over time (an audit of study enrolment/withdrawal logs)[One year after randomisation]